Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-04 @ 4:00 PM
Study NCT ID:
NCT06620367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flap dehiscence', 'timeFrame': '14 days', 'description': 'the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins'}], 'secondaryOutcomes': [{'measure': 'bone gain', 'timeFrame': '6 months', 'description': 'bone gain will be assessed using cone beam computed tomography (CBCT)'}, {'measure': 'bone denisty', 'timeFrame': '6 months', 'description': 'cone beam computed tomography (CBCT) will be used to asses bone density'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Digital Guided Bone Regeneration']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are:\n\n* Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration?\n* What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.\n\nParticipants will:\n\n* Receive guided bone regeneration around implant\n* Visit the clinic after 2,7,14 days for detection any signs of flap dehiscence\n* Bone gain and bone density will be assessed after 6 months', 'detailedDescription': 'Twenty sites with ridge defects will be recruited for this study. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for clinical approval. The purpose of the present study will be explained to the patients and informed consents will be obtained . Sites were randomly divided into 2 treatment groups .10 sites will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide \\& 10 sites will receive the same treatment except it will be guided using digitally designed guide. Membranes in both groups will be stabilized by tacks. Following clinical parameters will be recorded: the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2, 7 and 14 days, flap dehiscence. Also, bone gain and bone density will be assessed using cone beam computed tomography (CBCT) at baseline and 6 months post-surgery. The collected data was statistically analyzed at the different follow up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medium horizontal ridge defect according to clone classification\n* must have a general health showing no contraindications for surgery\n* must be at least 35 years old\n* patients also have adequate soft tissue thickness and width of keratinized gingiva\n\nExclusion Criteria:\n\n* no sign of uncontrolled systemic diseases\n* non smoker\n* not pregnant\n* sever ridge deficient\n* patients below 18 years old'}, 'identificationModule': {'nctId': 'NCT06620367', 'acronym': 'RCT', 'briefTitle': 'Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide', 'orgStudyIdInfo': {'id': '#R-OMPDR- 6-24-3122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional guided bone regeneration', 'description': 'a medium horizontal ridge defect will receive bone graft and covered with membrane', 'interventionNames': ['Procedure: conventional guided bone regeneration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'digital guided bone regeneration', 'description': 'digital designed guide will be used in a medium horizontal ridge defect to place bone graft and covered with membrane', 'interventionNames': ['Procedure: digital guided bone regeneration']}], 'interventions': [{'name': 'conventional guided bone regeneration', 'type': 'PROCEDURE', 'description': '10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane stabilized by tacks', 'armGroupLabels': ['conventional guided bone regeneration']}, {'name': 'digital guided bone regeneration', 'type': 'PROCEDURE', 'description': '10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) placed by digital designed guide covered with bilayer collagen membrane stabilized by tacks', 'armGroupLabels': ['digital guided bone regeneration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'faculty of dentistry Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Bassem nabil elfahl, assistant professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry Tanta university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of periodontology', 'investigatorFullName': 'Mona Al-Ahmady El-Meligy', 'investigatorAffiliation': 'Tanta University'}}}}